Jane Smyth Email & Phone Number

Dublin, County Dublin, Ireland

Managing numerous teams and individuals including;Medical device testingIncoming Inspection Sample ManagementDocument ManagementLab Co-ordinatorLab SchedulerOther responsibilities include;Lead of Site Sustainability ChampionsInternal auditor trained

Dublin, County Dublin, Ireland

Medical device, NPI, Raw Materials, Incoming Inspection, QC Sample Management, Document management

County Dublin, Ireland

County Dublin, Ireland

Dublin 15

Senior Quality Control Analyst responsible for method transfers, validations, material qualification and in-process testing in a start up, GMP laboratory.- Operational Readiness QC representative- Facilitating Internal audits by QA for the QC laboratory- FDA audit preparation - KPI generation for QC activities- SME for Raw Material Qualification and testing for GMP production - In-process analysis of intermediates to facilitate manufacturing processes-Drug Substance testing and release- Experience and review of OOS, OOT, RCA, CAPA's, GMP topics, Deviations, Change Controls and Specifications- LCMS analysis and review of intermediates and Drug Substance

Waikato, New Zealand

As a technologist I was responsible for the development and validation of methods within an ISO 17025 accredited laboratory. Other responsibilities;- IANZ (International Accreditation New Zealand) accredited KTP (Key Technical Person)- Research and development- Key Signatory- Troubleshooting OOS/OOT results- Chemical analysis of honey for various compounds, chemical markers and sugars - UPLC-MS/MS, UPLC-UV and HPLC-IC- Efficient organisation and time management in order to achieve deadlines- Report writing - Training of Technicians, Analysts and Approvers- Review and approval of the work of peers and technicians- Reporting to the Executive Director- Implementing QC procedures

Newry

- Full chemical and physical stability analysis of finished dosage form pharmaceuticals to comply with US Pharmacopoeia guidelines (injectables, tablets, suspensions)- UPLC, HPLC and GC were the central analysis techniques- Efficient time management to produce on time results for reporting- Troubleshooting and documenting OOS and OOT results- Verification and calibration of instruments (HPLC, balances, Moisture meter, pH meters etc.)- GDP to maintain trace-ability for audit compliance.- FDA audit preparation- Instrument maintenance

Newry

- Physical and chemical analysis of raw materials for quality control release- Analysis of a range of bulk and filled products to comply with a range of pharmacopoeia standards (USP, EP, BP and JP) - Road Tanker testing and release- Working independently and as part of a team to ensure the timely release of raw materials for production - HPLC, GC, FTIR, NIR, UV, AAS, wet chemistry techniques, troubleshooting- OOS investigation and documentation- Training fellow employees on systems, techniques and GMP processes

Navan S.C.

My key responsibilities included;- Recommending OTC medications to customers to treat common ailments- Keeping up to date knowledge of medication- Working in a busy atmosphere- Dealing with business banking- Cashing up tills - Dealing with brand representatives- Placing drug and product orders- The sole key holder at weekends and holidays

Bachelor Of Science (Bsc Hons), International Environmental Science And Health, 1.1

Activities and Societies: Rugby Society-Graduated in 2013 from DCU with a 1st Class Honors in International Environmental Science.

Bachelor'S Degree Environmental Science And Health, Physical Sciences

Successfully completed a semester in UOW Australia as part of the international module.

Leaving Certificate, Chemistry, Biology, Business, Maths, French, Irish, English., 480

Activities and Societies: Hockey